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Monogram Biosciences Launches First Resistance Assay for HIV Integrase Inhibitors
Date:8/4/2008

additional new agents is not likely to provide treatment options beyond our current choices for a number of years," said Dr. Charles Hicks, Associate Professor of Medicine at Duke University Medical Center. "Tools like HIV resistance phenotype tests (including Monogram's PhenoSense Integrase and PhenoSense GT assays) and the HIV tropism assay (Trofile(TM)) are important tools to help clinicians make good choices. They can also help with modifying regimens that are not suppressive by determining whether additional resistance has emerged and which drugs are no longer active."

"As the first and only commercially available assay to measure integrase inhibitor resistance, PhenoSense Integrase exemplifies Monogram's leadership position in personalized medicine and the Company's continued commitment to develop innovative HIV diagnostics that tailor drug treatments to the individual patient," said Monogram CEO William Young. "As evidenced by today's product launch and last year's introduction of Trofile, Monogram is firmly committed to ensuring that cutting-edge diagnostics are readily available to meet the needs of patients and physicians."

The performance of the PhenoSense Integrase assay is validated in compliance with regulations specified by the Clinical Laboratories Improvement Amendments (CLIA) and is performed in Monogram's Clinical Reference Laboratory, which is accredited by the College of American Pathologists (CAP).

About PhenoSense Integrase Assay

PhenoSense Integrase determines the susceptibility of a patient's HIV-1 strain to integrase inhibitors. The region of the HIV genome that encodes integrase is amplified from a patient blood sample and inserted into a proprietary test vector that is used to generate virus particles that replicate using the patient virus integrase protein. Completion of a single replication cycle results in the production of luciferase activity in infected cells. Infection in the presence of drug is performed
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SOURCE Monogram Biosciences, Inc.
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